CryptoCard: The Effect of Device Closure of Patent Foramen Ovale in Elderly Patients With Crytogenic Stoke/TCI

Sponsor

Hillerod Hospital, Denmark (Other)

Overall Status

Terminated

CT.gov ID

NCT01018355

Collaborator

(none)

3,000

Enrollment

Location

Arms

Duration (Months)

44.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective is to evaluate if patent foramen ovale (PFO) closure and antiplatelet medical management can reduce the risk of recurrent stroke or transient ischemic attack (TIA) when compared to antiplatelet medical management alone in elderly patients above 50 years of age with a PFO and a history of cryptogenic stroke or TIA.

Condition or Disease	Intervention/Treatment	Phase
Patent Foramen Ovale PFO Stroke TIA	Device: Percutaneous device closure of patent foramen ovale	N/A

Detailed Description

Prior to birth the fetal heart has a connection between the two atrias of the heart. After labour this connection often closes. About 10-15 % these connections remains open. This phenomenon is called patent foramen ovale or PFO, and is in most cases unsymptomatic.

The prevalence of PFO in patients with crytogenic (without known causes) stroke is much higher (about 40%)than the general population (about 10%). This has led to the theory that the presence of PFO can lead to stroke, by the passage of emboli from the peripheral venous circulation through the PFO to the brain by right-to-left shunting of the blood.

There are no existing data from prospective randomized studies focusing on the effect of device closure PFO in patients with cryptogenic stroke. Some observational retrospective studies have shown a beneficial effect in the reduction of recurrent stoke in patients younger that 50 years with cryptogenic stroke when PFO has been closed with a percutaneous device closure(PCD). Some studies have reported an 0% to 3.4% annual recurrence rate of stroke or TIA in patients treated with PDC. The recurrence rate of stroke or TIA in patients with crytogenic stroke or TIA in ordinary antithrombotic treatment is about 5-15 %.

The primary objective of this study is to assess whether percutaneous device closure of patent foramen ovale is superior to conventional antithrombotic treatment in preventing stroke recurrence in elderly patients above 50 years of age.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

3000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

The Effect of Device Closure of Patent Foramen Ovale in Elderly Patients With Crytogenic Stoke/TCI

Study Start Date :

Oct 1, 2009

Anticipated Primary Completion Date :

Sep 1, 2011

Anticipated Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Device closure of PFO Device closure of PFO followed by 6 month treatment with clopidogrel 75 mg and 75 - 150 mg of aspirin daily followed by a life long treatment with dipyridamol 200 mg twice daily plus 75-150 mg aspirin daily	Device: Percutaneous device closure of patent foramen ovale Percutaneous device closure of patent foramen ovale
Active Comparator: Medical anticoagulative treatment Life long treatment with dipyridamol 200 mg twice daily plus 75-150 mg aspirin daily	Device: Percutaneous device closure of patent foramen ovale Percutaneous device closure of patent foramen ovale

Arm

Intervention/Treatment

Experimental: Device closure of PFO

Device closure of PFO followed by 6 month treatment with clopidogrel 75 mg and 75 - 150 mg of aspirin daily followed by a life long treatment with dipyridamol 200 mg twice daily plus 75-150 mg aspirin daily

Device: Percutaneous device closure of patent foramen ovale

Percutaneous device closure of patent foramen ovale

Active Comparator: Medical anticoagulative treatment

Life long treatment with dipyridamol 200 mg twice daily plus 75-150 mg aspirin daily

Device: Percutaneous device closure of patent foramen ovale

Percutaneous device closure of patent foramen ovale

Outcome Measures

Primary Outcome Measures

Combined endpoint defined by the time from intervention to either fatal og non-fatal stroke/TIA [Endpoints assessed every half year starting 1 year after intervention]

Secondary Outcome Measures

ct-verified stroke 2 years after intervention [2 years after intervention]
Death by other causes than Stroke [Endpoint assessed every half year starting 1 year after intervention]
Examination of residual cardiac right to left shunt after device closure of PFO [1 month after intervention]
Complications to device closure of PFO [few days after intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:

51 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Stroke or TIA within 30 days
Above 50 years of age

Exclusion Criteria:

Deceases og the esophagus
Dementia
Allergy to aspirin
Risk of non-compliance
Lacking ability to give written or oral consent
Atrial Fibrillation
Neurological deficit lasting less than 6 hours

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept. of cardiology and endocrinology H	Hillerød	Region H	Denmark	3400

Sponsors and Collaborators

Hillerod Hospital, Denmark

Investigators

Principal Investigator: Christian S Hansen, dr., Hillerød Hospital. dept. of cardiology and endocrinology
Study Director: Niels Tønder, Dr., Hillerød Hospital. dept. of cardiology and endocrinology
Study Director: Kasper K Iversen, Dr., Hillerød Hospital. dept. of cardiology and endocrinology